Page 135 - 00. Complete Version - Progress Report IPEN 2014-2016

Radiopharmacy | Progress Report 135

Quality control of radiopharmaceuticals

Quality Control is part of the Good Manufacturing Practices (GMP) which is concerned to sam-
pling, specifications and testing, and also to organization, documentation and release proce-
dures which ensure that the necessary and relevant tests are actually carried out and the radio-
pharmaceutical drugs are not released for use by the responsible radiopharmacist until their
quality is guaranteed. Radiopharmaceuticals are transported to the nuclear medicine services
in accordance with the radiation protection regulation. Nowadays, about 80,000 assays are
executed in radionuclides including eluates from radionuclide generators, ready to use radio-
pharmaceuticals, non-radioactive components for labeling with a radionuclide, starting ma-
terials, packaging materials and environmental monitoring at the Radiopharmacy Center of
IPEN-CNEN/SP. In order to evaluate if radiopharmaceuticals comply with the specifications of
national and international pharmacopoeias and official standards for oral and parenteral hu-
man administration(,) strict quality control tests are performed.

Specific tests that ensure purity, potency, product identity, biologic safety and efficacy include
physicochemical and biological tests: organoleptic characteristics, pH, particle size measure-
ment, determination of radionuclidic, radiochemical and chemical purity, capsules dissolution
testing, sterility, bacterial endotoxin test, biodistribution and toxicity studies, among others.
The Quality Control has adequate facilities with modern analytical equipment for its activities.
Instrumental techniques as gamma counters, IR spectrophotometry, GC, ICP-OES, HPLC and
gamma spectrometry with HPGe detector are used. Environmental monitoring is conducted
in the production areas (hot cells and clean areas) by collecting and measuring airborne parti-
cles as well as microbiological contamination is assessed with passive and active air sampling.
The quality of water used in different processes is also examined. Training of professionals of
Nuclear Medicine also takes place in the laboratories of the Quality Control. The staff of the
Quality Control (QC) Laboratory is trained and qualified and participates actively with all the
other groups in the maintenance of the ISO 9001-2015 Certification, in compliance with GMP
for radiopharmaceuticals. The QC group is also engaged in the qualification of equipment, de-
velopment and validation of analytical methodologies, validation of production processes, ob-
serving the requirements of the National Sanitary Surveillance Agency (ANVISA) and it has
also been participating in the development of new products.

Research and Development

The area of Research and Development applied to Radiopharmacy at IPEN is divided into 6 dif-
ferent fields: Radionuclide generators; Primary radioisotopes; Labeling of molecules for diagno-
sis (PET and SPECT) and therapy; lyophilized kits and quality control analytical methodologies.

The main achievements are described as follows:

Radionuclide generators
99
• Study of high activity Mo- 99m Tc generators
• Study of different Sep-PaksÆ filters for using in 99M o/99mTc generators